Lepore 1989.

Study characteristics
Methods	Design: RCT, parallel two‐arm, single‐centre study Setting: university teaching hospital, Gothenburg, Sweden Recruitment: recruitment and study dates not reported Maximum follow‐up: 5 days postoperatively
Participants	135 participants undergoing cardiac surgery were randomised to one of two groups: Autotransfusion group (Cell salvage/intervention group): N = 67. M:F 52:15. Mean (SD) age 60 (12) Control group: N = 68. M:F 51:17. Mean (SD) age 61 (10) Participants in the autotransfusion group were comparable to those in the control group at baseline.
Interventions	Autotransfusion group (Cell salvage/intervention group): cell salvage group had the cardiotomy reservoir (Dideco 742), after use in extracorporeal circulation, reconfigured to serve as a receptacle for postoperative mediastinal drainage. One of the inlet ports was connected to the tubes draining the mediastinum. In this way, the drainage from the chest passed through the 20 µm filter of the cardiotomy reservoir. The cardiotomy outlet tubing was replaced with an adaptor connecting with standard intravenous tubing. A standard infusion pump was used to reinfuse the collected blood. The filtered blood collecting in the reservoir was reinfused at hourly intervals. No blood was reinfused after the 6th postoperative hour. Thereafter, the reservoir served only as a receptacle for shed mediastinal blood. Reservoir blood was sampled at 6 hours for bacteriologic study. Control group: control group received no autotransfusion.
Outcomes	Outcomes reported: amount of blood re‐transfused from the cell saver, amount of allogeneic blood transfused, number of participants transfused allogeneic blood, adverse events, mortality, blood loss
Notes	Transfusion protocol: the use of a transfusion protocol was not reported. Prospective registration status: the study was published prior to 2010. Ethical approval: the study was approved by the hospital Ethic's Committee. Language of publication: English Trial funding: not reported Conflicts of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method used to generate allocation sequences was not described.
Allocation concealment (selection bias)	Unclear risk	Method used to conceal treatment allocation was unclear.
Blinding of participants and personnel (performance bias) Objective outcome: mortality	Low risk	Objective outcome (mortality) unlikely to be influenced by blinding
Blinding of participants and personnel (performance bias) Subjective: transfusion protocol	High risk	No transfusion protocol in place
Blinding of participants and personnel (performance bias) Subjective: all other outcomes	Unclear risk	No blinding possible for personnel
Blinding of outcome assessment (detection bias) Objective outcomes: mortality and transfusions	Low risk	Objective outcome (mortality) unlikely to be influenced by blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding possible for personnel
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No info on participant flow. Baseline characteristics as mentioned in methods as number who were allocated to each group. Unclear if this is the number used in analyses (1 participant died, unclear if they were excluded ‐ no mention). Likely ITT, but not sure
Selective reporting (reporting bias)	Unclear risk	No trial registration or published protocol is available to compare
Other bias	Unclear risk	No baseline imbalance noted. Funding and conflicts not reported